NCT02462694

Brief Summary

Suicide is a pressing problem in the US military, with evidence of increased risk for suicide particularly among soldiers serving in Iraq and Afghanistan. To date, there are very few studies that empirically evaluate treatment efficacy to prevent suicide. One treatment that has been shown empirically to decrease suicidal behavior is Dialectical Behavioral Therapy (DBT), although these studies have been limited to patients with borderline personality disorder (BPD). The current proposal aims to examine the efficacy of DBT in reducing suicidal behavior more broadly in a diagnostically heterogeneous group of veterans with high risk suicidal behavior. One of the difficulties in doing research in suicide prevention is that serious suicidal behavior is a relatively rare event, and alone is not a satisfactory target for treatment studies. It is extremely important, therefore, to identify intermediate symptoms that are closely associated with high risk suicidal behaviors, as targets for treatment. One critical area our proposal addresses is validating new treatment models for suicide in veterans; DBT has been empirically validated to reduce suicidal behavior in individuals with BPD, but has not been tested more broadly to target suicidal behaviors. The second critical area which our proposal addresses is exploring new suicide risk assessment measures. While the investigators do not specifically propose to develop new screening tools, the investigators do propose to identify potentially important domains that specifically differentiate ill high risk suicide veterans from low risk. This information will be useful in future efforts to modify the DBT approach to be more effective for the broader diagnostic group of high risk suicidal veterans.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

7.3 years

First QC Date

June 2, 2015

Last Update Submit

January 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Counting of suicidal events

    Utilizing the The Columbia Suicide Severity Rating Scale

    6 months

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Treatment as usual (TAU): Standard psychological, psychopharmacology and case management services

Behavioral: Treatment As Usual

Dialectical Behavior Therapy

EXPERIMENTAL

Standard Dialectical Behavior Therapy (DBT): weekly individual sessions, skills training group and telephone coaching as needed

Behavioral: Dialectical Behavior Therapy

Interventions

Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD

Dialectical Behavior Therapy

TAU for these subjects involves close tracking by the Suicide Prevention Coordinator and treatment by their individual team of clinicians. Additionally, a support group with psychoeducation about suicide prevention will be offered as part of TAU

Treatment as Usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans between the ages of 18 and 65
  • Able to give consent
  • Recent admission to psychiatric inpatient unit (6B)

You may not qualify if:

  • Lifetime or current diagnosis of schizophrenia or other psychotic disorder; current psychosis from affective disorder
  • IQ\<80
  • Current evidence or history of significant organic brain impairment, including stroke, CNS tumor, demyelinating disease, severe head trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Goodman M, Banthin D, Blair NJ, Mascitelli KA, Wilsnack J, Chen J, Messenger JW, Perez-Rodriguez MM, Triebwasser J, Koenigsberg HW, Goetz RR, Hazlett EA, New AS. A Randomized Trial of Dialectical Behavior Therapy in High-Risk Suicidal Veterans. J Clin Psychiatry. 2016 Dec;77(12):e1591-e1600. doi: 10.4088/JCP.15m10235.

MeSH Terms

Conditions

Suicide

Interventions

Dialectical Behavior TherapyTherapeutics

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marianne Goodman, MD

    James J. Peters Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marianne Goodman, MD

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 4, 2015

Study Start

April 1, 2010

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01